Preparation method of sterile tacrolimus nano suspension eye drops
A nano-suspension, tacrolimus technology, applied in the preparation of sterile nano-suspension eye drops, the field of preparation of sterile tacrolimus nano-suspension eye drops, can solve many aseptic operation steps. , Sterile difficulty, strong eye irritation, etc.
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Embodiment 1
[0063] 1. Prescription composition
[0064] Table 1 Example 1 The composition of the prescription in the preparation of sterile tacrolimus nano-suspension eye drops
[0065]
[0066] The concentration of tacrolimus in the suspension is about 10 times that of the finished product, the volume ratio of the organic solvent (absolute ethanol) to the aqueous phase is 15:100, the weight ratio of tacrolimus to the particle size stabilizing excipient polyvinyl alcohol It is 1:1.6.
[0067] 2. Preparation process:
[0068] (1) Preparation of tacrolimus nanosuspension
[0069] Weigh the prescribed amount of tacrolimus raw material, add it into an organic solvent (absolute ethanol in this example), stir and dissolve, and use it as the organic phase. Weigh the prescribed amount of stabilizing excipients (polyvinyl alcohol in this example) into water, stir to dissolve (the water phase can be heated in a water bath at 40-60°C, which is conducive to the rapid dissolution of polyvinyl al...
Embodiment 2
[0082] prescription composition
[0083] Table 2 The composition of the prescription in the preparation of the sterile tacrolimus nano-suspension eye drops of Example 2
[0084]
[0085] The concentration of tacrolimus in the suspension is about 30 times that of the finished product, the volume ratio of the organic solvent (absolute ethanol) to the aqueous phase is 1:20, the weight of tacrolimus and the particle size stabilizing excipient polyethylene glycol The ratio is 1:10.
Embodiment 3
[0087] prescription composition
[0088] Table 3 Example 3 The composition of the prescription in the preparation of sterile tacrolimus nano-suspension eye drops
[0089]
[0090] The concentration of tacrolimus in the suspension is about 5 times that of the finished product, the volume ratio of the organic solvent (absolute ethanol) to the water phase is 1:100, and the ratio of tacrolimus and particle size stable excipient hypromellose The weight ratio is 1:20.
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